DepressionNCT01869868
Neurobiological Changes When Treating Depression With Electroconvulsive Therapy - a Longitudinal Observational Study
An observational study of Depression, run by Linkoeping University at 1 site in Sweden.
Trial summary
The purpose of this study is to determine functional and structural changes in brain following treatment of severe depression with electroconvulsive therapy with correlation to clinical outcome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2013to Dec 2015
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with depression referred for ECT.
Who may be able to join
- major depressive disorder
- depressive episode in bipolar disorder
- age 18 - 65 years
Who cannot join
- alcohol- and/or drug dependence or abuse in the past 3 months
- severe/life-threatening medical disease
- pregnancy
- type I diabetes
- neurodegenerative disorder
- inability to give written informed consent to participation in the study
- contradiction to MRI scanning.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Linkoeping University, Linkoeping University Hospital
Linköping, Östergötland County, S58185
Pia Nordanskog, MD, +46101030000, pia.nordanskog@lio.se
Pia Nordanskog, MD
About this study
Official title: Neurobiological Changes and Clinical Outcome When Treating Depression With Electroconvulsive Therapy.
The purpose of this study is to determine functional and structural changes in brain following treatment of severe depression with electroconvulsive therapy with correlation to clinical outcome. Our hypothesis is that there are state-dependent changes in functional connectivity within specific neurocircuits systems, as well as structural plasticity changes in hippocampus, when recovering from depression.
Read the detailed description
The study is a prospective, within-subject, observational follow-up study in individuals with depression who receive electroconvulsive therapy (ECT)at a psychiatric clinic. We will use a consecutive sampling method and patient referred for ECT by their psychiatrist will be screened for inclusion and asked for participation. Both in - and outpatients can be included. At three occasions (before treatment, after four week and after three months) patients will be assessed with clinical ratings, cognitive tests, functional and structural magnetic resonance imaging and biomarkers for cell proliferation.
- Conditions
- Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Depression, ECT | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measures of hippocampal volume assessed by structural MRI
Measured: Three months
fMRI BOLD resting state functional connectivity
Measured: 3 month
fMRI BOLD responses during execution of emotional and reward processing tasks
Measured: 3 months
Biomarkers of cell proliferation
Measured: 3 months
Secondary outcomes (1)
Relation between neurobiological changes and clinical and cognitive outcome
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Pia Nordanskog, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869868
- Sponsor's protocol ID
- LIU2012/310-31
- Other IDs
- LinkoepingUniversity
- Status last verified
- Apr 2015
- First submitted
- 2 Jun 2013
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiological Changes and Clinical Outcome When Treating Depression With Electroconvulsive Therapy.
- ClinicalTrials.gov ID
- NCT01869868
- Acronym / sponsor ID
- LIU2012/310-31
- Conditions
- Depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (estimated)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine functional and structural changes in brain following treatment of severe depression with electroconvulsive therapy with correlation to clinical outcome. Our hypothesis is that there are state-dependent changes in functional connectivity within specific neurocircuits systems, as well as structural plasticity changes in hippocampus, when recovering from depression.
Detailed description
The study is a prospective, within-subject, observational follow-up study in individuals with depression who receive electroconvulsive therapy (ECT)at a psychiatric clinic. We will use a consecutive sampling method and patient referred for ECT by their psychiatrist will be screened for inclusion and asked for participation. Both in - and outpatients can be included. At three occasions (before treatment, after four week and after three months) patients will be assessed with clinical ratings, cognitive tests, functional and structural magnetic resonance imaging and biomarkers for cell proliferation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Depression, ECT | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with depression referred for ECT.
Key inclusion criteria (3 listed)
- major depressive disorder
- depressive episode in bipolar disorder
- age 18 - 65 years
Key exclusion criteria (7 listed)
- alcohol- and/or drug dependence or abuse in the past 3 months
- severe/life-threatening medical disease
- pregnancy
- type I diabetes
- neurodegenerative disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measures of hippocampal volume assessed by structural MRI
Time frame: Three months
fMRI BOLD resting state functional connectivity
Time frame: 3 month
fMRI BOLD responses during execution of emotional and reward processing tasks
Time frame: 3 months
Biomarkers of cell proliferation
Time frame: 3 months
1 secondary outcome
Relation between neurobiological changes and clinical and cognitive outcome
Time frame: Three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
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Survivorship
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linkoeping University, Linkoeping University Hospital
Linköping, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measures of hippocampal volume assessed by structural MRI (time frame: Three months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2015.